WO2021201074A1

WO2021201074A1 - Medical syringe barrel, and packaging for same

Info

Publication number: WO2021201074A1
Application number: PCT/JP2021/013775
Authority: WO
Inventors: 孝之吉田
Original assignee: 株式会社大協精工
Priority date: 2020-03-31
Filing date: 2021-03-31
Publication date: 2021-10-07
Also published as: CA3176289A1; TW202203995A; US20230146155A1; JPWO2021201074A1; EP4129360A1; EP4129360A4; AU2021245680A1; CN115397492A; KR20220160658A

Abstract

[Problem] To provide a medical syringe barrel and packaging for the same with which an adequate stroke in operation is ensured even with a Luer-Lok-type low-capacity syringe, and which prevent unsteadiness or facilitate a drawing action when the syringe is held by a nested cylindrical member and transported. [Solution] A medical syringe barrel including a tubular trunk part for accommodating a peroral liquid in the interior thereof, a cylindrical ejection nozzle part formed on one end of the trunk part, and a flange part that is provided to an opening at the other end of the trunk part and that protrudes radially outward, wherein the trunk part includes an intermediate trunk part that is smaller in outside diameter than the ejection nozzle part, and a large-outside-diameter trunk part that has the same outside diameter as the ejection nozzle part and that is formed between the flange part and the intermediate trunk part.

Description

Medical syringe barrel and its packaging

The present invention relates to a syringe barrel constituting a medical syringe and a package for transporting the syringe barrel.

In general, a medical syringe consists of a syringe barrel to which an injection needle is attached to the tip and a syringe plunger that is inserted through an opening at the other end to move the piston in the axial direction, and is provided at the opening at the other end of the syringe barrel. Is provided with a flange that projects outward in its radial direction. There are luer tip type, luer lock type, etc. as the type of the tip of the syringe to which the injection needle is attached, and the structure for fixing the injection needle is defined by the ISO standard from the viewpoint of preventing medical accidents. The luer lock type has a lock function at the tip of the syringe and is suitable for when you want to firmly connect the injection needle.

The outer diameter of the luer lock, which is the tip of the syringe barrel, is defined by the ISO standard, but for small-capacity syringes, it is necessary to take a predetermined stroke for ease of use during injection. It is necessary to reduce the inner diameter of the barrel body filled with the liquid. When a syringe barrel in which the outer diameter of the barrel body portion is equal to the outer diameter of the luer lock portion is manufactured by injection molding of a thermoplastic resin, molding defects occur in the barrel body portion where the wall thickness becomes large. Therefore, as described in Patent Document 1, a barrel has been proposed in which the outer diameter of the barrel body portion is made smaller than the outer diameter of the luer lock portion to ensure a sufficient stroke. Further, Patent Document 2 discloses a structure of a syringe barrel provided with a large diameter portion having an inner diameter larger than the inner diameter of the intermediate portion on the terminal side thereof.

In addition, a prefilled syringe pre-filled with an accurate dose is used for simplification of drug management, infection prevention, error prevention during adjustment, and rapid administration. Generally, syringe assembly parts such as syringe barrels, pistons, and plungers are transported to a pharmaceutical company, filled with an internal solution, and assembled. For this reason, it is necessary to transport the syringe while maintaining the sterilized state, and it has been proposed to use a container consisting of a nest and a tab as shown in Patent Documents 3 and 4, for example.

Japanese Unexamined Patent Publication No. 2013-116289 Design Registration No. 1468280 International Patent Publication WO2014 / 109011A1 Gazette Japanese Patent No. 6040025

When the syringe barrel disclosed in Patent Documents 1 and 2 is housed in a nest as shown in Patent Documents 3 and 4, it is transported to a pharmaceutical company or the like assembled as a prefilled syringe together with other parts such as a piston and a plunger. Occasionally there is rattling in the nest. This rattling may cause damage due to contact between the members during transportation, and may cause a problem when the members are pulled out from the nest.

Therefore, it is required to provide a syringe barrel and a package thereof that prevent undesired contact between members and enable easy pulling-out operation during transportation in the nest and when pulling out from the nest.

(1) The medical syringe barrel according to the present invention has a cylindrical body for accommodating an internal liquid, a cylindrical injection nozzle formed at one end of the body, and the other end of the body. Includes a flange that protrudes outward in the radial direction provided in the opening of the.
The body has an intermediate body having an outer diameter smaller than the outer diameter of the injection nozzle, and a large outer diameter body having the same outer diameter as the outer diameter of the injection nozzle formed between the flange and the intermediate body. including.

When the medical syringe barrel configured in this way is inserted into the nested tubular member from above with the injection nozzle portion facing down, the ejection nozzle portion having an outer diameter slightly smaller than the inner diameter of the nested tubular member is a cylinder. The syringe barrel is housed in the cylindrical member by passing through the cylindrical member, entering the cylindrical member in the order of the intermediate body portion and the large outer diameter body portion, and contacting the flange portion with the upper end of the tubular member. ..

By providing a large outer diameter body portion having the same outer diameter as the outer diameter of the injection nozzle portion, it is possible to suppress rattling of the syringe barrel in the tubular member when it is housed in the nest and transported. .. In addition, the central axis of the tubular member and the central axis of the syringe barrel coincide with each other, and misalignment is less likely to occur. Further, it becomes easy to pull out the syringe barrel straight from the tubular member.

(2) The present invention is characterized in that, in the medical syringe barrel of (1), the axial length of the large outer diameter body portion is set to 1/3 or less of the axial length of the body portion. do.

By setting the large outer diameter body to an appropriate length in this way, it is more effective to suppress rattling of the syringe barrel in the tubular member, prevent misalignment, and facilitate pulling out of the syringe barrel from the tubular member. Can be. On the other hand, if the large outer diameter body portion is too long, there is an inconvenience that the distance from the opening on the flange portion side of the syringe barrel to the specified piston position (specified internal capacity filling position) becomes long when the piston is evacuated. Therefore, it is preferable to set the axial length of the large outer diameter body portion to 1/3 or less of the axial length of the body portion.

(3) The package of the medical syringe barrel according to the present invention has a flat plate-shaped member provided with at least one opening, and a cylindrical shape formed as a protruding end in which one end is connected to the opening and the other end projects upward. At least one syringe barrel is held in a nest having a member.

The syringe barrel held in the nest has a tubular body for accommodating internal liquid, a cylindrical injection nozzle formed at one end of the body, and an opening at the other end of the body. The body has an intermediate body having an outer diameter smaller than the outer diameter of the injection nozzle, and an injection formed between the flange and the intermediate body. Includes a large outer diameter body with the same outer diameter as the outer diameter of the nozzle.

The inner diameter of the tubular member is set to be larger than the outer diameter of the large outer diameter body portion and smaller than the outer diameter of the flange portion, and the flange portion abuts on the protruding end of the tubular member, and at least one of the body portions. The portion is held in the tubular member.

In the package of the medical syringe barrel configured in this way, when the injection nozzle portion is inserted into the nested tubular member from above with the injection nozzle portion facing down, the injection nozzle having an outer diameter slightly smaller than the inner diameter of the nested tubular member is slightly smaller. The portion passes through the cylindrical member, enters the cylindrical member in the order of the intermediate body portion and the large outer diameter body portion, and the flange portion contacts the upper end of the tubular member, so that the syringe barrel becomes the tubular member. Be housed. Twice

By providing the syringe barrel with a large outer diameter body portion having the same outer diameter as the outer diameter of the injection nozzle portion, it is possible to suppress rattling of the syringe barrel in the tubular member when transporting such a package. Is possible. In addition, the central axis of the tubular member and the central axis of the syringe barrel coincide with each other, and misalignment is less likely to occur. Further, it becomes easy to pull out the syringe barrel straight from the tubular member.

(4) In the present invention, in the package of the medical syringe barrel of (3), the axial length of the large outer diameter body portion is set to 1/3 or less of the axial length of the body portion. It is characterized by.

By setting the large outer diameter body to an appropriate length in this way, it is more effective to suppress rattling of the syringe barrel in the tubular member, prevent misalignment, and facilitate pulling out of the syringe barrel from the tubular member. Can be. On the other hand, if the large outer diameter body portion is too long, there is a disadvantage that the distance from the opening of the flange portion of the syringe barrel to the specified piston position (specified internal capacity filling position) becomes long when the piston is evacuated. Therefore, it is preferable to set the axial length of the large outer diameter body portion to 1/3 or less of the axial length of the body portion.

According to the medical syringe barrel of the present invention and its packaging, a sufficient stroke is secured for operation even in a luer lock type small-capacity syringe, and rattling occurs when the syringe is held in a nested tubular member and transported. It can be prevented and the pulling operation can be facilitated.

(A) is a perspective view showing a configuration example of a medical syringe in which a syringe barrel according to an embodiment of the present invention is filled with an internal liquid and assembled together with a piston, a plunger and a finger grip. ) Is a perspective view of the medical syringe shown in (A) as viewed from another angle. (A) is an axial sectional view of a syringe barrel according to an embodiment of the present invention, and (B) is a side view seen from arrow B in (A). It is a perspective view which shows the schematic structure of the container used for the packaging body of the medical syringe barrel according to one Embodiment of this invention. It is a partial cross-sectional view of the package body of the medical syringe barrel according to one Embodiment of this invention. It is a perspective view which shows the appearance of the container used for the packaging body of the medical syringe barrel according to one Embodiment of this invention. It is a figure which shows an example of the use of the toe of the arm for handling a syringe barrel in the package of the medical syringe barrel according to one Embodiment of this invention.

Hereinafter, the configuration of the medical syringe barrel according to the embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a perspective view showing a configuration example of a medical syringe in which a syringe barrel according to an embodiment of the present invention is filled with an internal liquid and assembled together with a piston, a plunger and a finger grip. This medical syringe is, for example, an extremely small-capacity prefilled syringe for ophthalmology, and is a disposable syringe intended for single use.

In FIG. 1, the syringe 10 is an assembly of a syringe barrel 20, a finger grip 30, a syringe plunger 40, and a piston 50. The internal liquid 60 is housed in the hollow portion of the cylindrical syringe barrel 20, and the internal liquid 60 is pushed out from the tip of the syringe barrel 20 by pushing the piston 50 with the tip of the syringe plunger 40. As shown in FIG. 1, the syringe barrel 20 is, for example, a transparent tubular body of a molded product such as glass or polyolefin resin, and is formed of an internal liquid 60, a piston 50, and a syringe plunger 40 in a hollow portion. Part of it is visible.

FIG. 2 is an axial cross-sectional view showing the configuration of the syringe barrel 20 according to the embodiment of the present invention. The syringe barrel 20 is a molded product obtained by injection molding of a synthetic resin such as a polyolefin resin, and has a tubular body 21 for accommodating an internal liquid inside, for example, an injection formed at one end of the body 21. It is composed of an injection nozzle portion 22 to which a needle is attached, and a flange portion 23 provided in an opening at the other end of the body portion 21 and protruding outward in the radial direction. The syringe barrel 20 is used, for example, in a 0.25 mL ophthalmic syringe having a very small volume.

In FIG. 2A, the injection nozzle portion 22 is formed as a luer lock type, conforms to the ISO80369-7 standard, and is a cylindrical nozzle cylinder portion having a tapered surface tapered toward the tip on the outer periphery. A screw cylinder portion having a male screw on the inner wall surface is connected to the outside. With this structure, the injection needles are firmly aligned so that the attached injection needles can be prevented from loosening or coming off from the nozzle when used in a medical field or the like. It has become. In addition, such a syringe barrel 20 may be used for mixed injection into a drip portion, or as a syringe for mixing two drugs between syringes.

Since the injection nozzle portion 22 complies with the international standard ISO80369-7 for preventing erroneous connection, its shape and the like are defined by the standard. In FIG. 2, the axial length C of the screw cylinder portion of the injection nozzle portion 22 is 70% or more of the outer diameter D22 thereof. As shown in FIG. 2 (B), when the flange 23 is viewed from the direction of the arrow B in FIG. 2 (A), the flange 23 has a shape in which both ends of the two arcs are connected by a straight line. doing. Further, it seems that the inner wall 22N of the nozzle cylinder portion inside the injection nozzle portion 22, the inner wall 21N of the intermediate body portion 21M, and the inner wall 25N of the large outer diameter body portion 24 are arranged concentrically.

With a 0.25 mL syringe with a very small volume such as for ophthalmology, it is necessary to take a predetermined stroke for ease of use such as during injection, so the barrel body (intermediate body 21M) filled with the internal solution The inner diameter (diameter of the inner wall 21N) is reduced.

By the way, in a normal syringe barrel having the same outer diameter from the injection nozzle to the end of the body (immediately before the flange), if the inner diameter of the intermediate body is reduced, the barrel body becomes thicker, causing molding defects called sink marks. .. In the present embodiment, since the syringe barrel 20 is an injection-molded product of synthetic resin, in order to prevent molding defects such as sink marks due to injection molding, the wall thickness of the intermediate body portion 21M is not increased, and the intermediate body portion is formed. The outer diameter D21 of 21M is reduced. A large outer diameter body portion 24 having a larger outer diameter than the intermediate body portion 21M is provided between the flange portion 23 and the intermediate body portion 21M. The wall thickness of the large outer diameter body portion 24 is set to be equal to the wall thickness of the intermediate body portion 21M, and the inner diameter of the large outer diameter body portion 24 (diameter of the inner wall 24N) is set large.

The outer diameter D24 of the large outer diameter body portion 24 is set to be equal to the outer diameter D22 of the screw cylinder portion of the injection nozzle portion 22. The outer diameter D21 of the intermediate body portion 21M is preferably 50% or more of the outer diameter D22 of the injection nozzle portion 22 or the outer diameter D24 of the large outer diameter body portion 24. The flange portion 23 and the large outer diameter body portion 24 are continuous connecting portions with a radius. The large outer diameter body portion 24 and the intermediate body portion 21M are connected by a tapered portion.

The axial length d of the portion of the large outer diameter body portion 24 that is equal to the outer diameter D22 of the injection nozzle portion 22 is the length of the intermediate body portion 21M required for making a syringe having an extremely small capacity, and the vacuum striking of the piston. It is determined in consideration of the length of the intermediate body portion 21M required for the plug. If the axial length d of the portion of the large outer diameter body portion 24 that is equal to the outer diameter D22 of the injection nozzle portion 22 is too long, when the piston is evacuated, the piston is specified at the specified position from the opening (specified internal capacity filling position). There is an inconvenience that the distance to is long. The specified piston position is not set in the portion having an inner diameter larger than the inner diameter of the intermediate body portion 21M for accommodating the internal liquid.

From this point of view, in relation to the length L of the body 21 of the syringe barrel 20, the axial length d of the portion of the large outer diameter body 24 equal to the outer diameter D22 of the injection nozzle 22 is L. It is set in the range of / 3 ≧ d> 0.

When transporting the syringe barrel 20 configured in this way to a pharmaceutical company or the like, a medical device container composed of nests and tabs as shown in FIG. 3 is used. The container 300 comprises a nest 310, tabs 320, and film 330. The nest 310 is provided with a plurality of cylindrical members 312 projecting above the flat plate member 311. The flat plate-shaped member 311 is provided with a plurality of openings, and one end of the cylindrical member 312 is connected to each opening, and the other end is a protruding end protruding upward. The inner diameter of each opening and the inner diameter of each cylindrical member 312 are equal, and are provided so that their centers coincide with each other.

Each cylindrical member 312 functions as a holder for holding the syringe barrel 20. As shown in FIG. 4, the inner diameter a of the tubular member 312 is larger than the outer diameter D24 of the large outer diameter body portion 24, and the shortest outer diameter b of the flange portion 23 is larger than the inner diameter a of the tubular member 312. Is also set large. The flange portion 23 comes into contact with the protruding end of the tubular member 312, and a part of the body portion 21 is held in the tubular member 312.

In this embodiment, the length of the large outer diameter body portion 24 obtained by adding the thickness of the flange portion 23 to the axial length d of the portion equal to the outer diameter D22 of the injection nozzle portion 22 is Lb, and the shaft of the tubular member 312. Assuming that the length obtained by adding the thickness of the flat plate member 211 to the directional length is La, the length Lb is preferably 40% to 60% of the length La. The length La is defined by the ISO standard.

As shown in FIG. 3, a nest 310 in which a plurality of syringe barrels 20 are held in each of the plurality of tubular members 312 is housed in the tab 320, and the nest 310 is sealed with a gas impermeable film 330 to seal the medical treatment shown in FIG. A package of a medical syringe barrel is composed of a container 300 for an instrument. This sterilized package is transported to a pharmaceutical company, medical institution, etc. When the syringe barrel 20 is for a prefilled syringe, the pharmaceutical company can open the container 300 and immediately fill the internal liquid.

In addition, as a packaging form other than sealing the opening with the gas impermeable film described above,
(1) A method of sealing the tab opening with a gas permeable film and then packaging the entire tab under reduced pressure.
(2) A method of sealing the opening with a gas permeable film and then sealing the gas permeable film from above the gas permeable film under reduced pressure conditions.
(3) There are packaging methods other than the above that can be packaged and transported while maintaining the cleanliness inside the tab at an appropriate control value, and any of these packaging methods or other known packaging forms are also implemented. Applicable to morphology.

Next, the operation of the medical syringe barrel of this embodiment and its package will be described. A syringe barrel 20 having the shape shown in FIG. 2 is manufactured by injection molding of synthetic resin, and as shown in FIG. 6, the flange portion 23 is formed by the toe 600 of the arm with the injection nozzle portion 22 facing downward by an automated process. In support, the injection nozzle portion 22, the intermediate body portion 21, and the large outer diameter body portion 24 are inserted in this order from above the tubular member 312. By supporting the flange portion 23 at the protruding end of the tubular member 312, a part of the syringe barrel 20 is held by the tubular member 312.

The outer diameter D22 of the injection nozzle portion 22 and the outer diameter D24 of the large outer diameter body portion 24 are equal, and the inner diameter a of the tubular member 312 is set to be slightly larger than the outer diameters D22 and D24 of the two portions. Rattling in the shape member 312 is prevented. When the container 300 is housed in the container 300 shown in FIG. 5 and transported to a pharmaceutical company, and the pharmaceutical company fills the internal liquid, the container 300 is opened, and as shown in FIG. Support and pull up the syringe barrel 20.

At this time, since the outer diameter D22 of the injection nozzle portion 22 and the outer diameter D24 of the large outer diameter body portion 24 are equal, the syringe barrel 20 is in a state where the central axis of the syringe barrel 20 and the central axis of the tubular member 312 are substantially aligned. Is raised. As a result, the syringe barrel 20 can be pulled straight out from the tubular member 312. Therefore, the pulling-out operation of the syringe barrel 20 is stable, and it is possible to prevent the syringe barrel 20 from colliding with a member such as the inner wall of the tubular member 312.

According to the embodiment described above, even in a luer lock type small-capacity syringe, a sufficient stroke is secured for operation, and when the syringe is held in the tubular member of the nest and transported, rattling is prevented or the pulling operation is performed. A medical syringe barrel and its packaging can be provided for facilitation. Further, the medical syringe barrel and the package thereof according to the present embodiment are suitable for a prefilled syringe that is assembled by filling the syringe barrel with a chemical solution in advance.

10 Syringe 20 Syringe barrel 21 Body 21M Intermediate body 22 Injection nozzle 23 Flange 24 Large outer diameter Body 30 Finger grip 40 Syringe plunger 50 Piston 60 Internal liquid 300 Container 310 Nest 311 Flat plate member 312 Cylindrical member 320 Tab 330 Film 600 Arm Toe

Claims

A cylindrical body for accommodating the internal liquid, a cylindrical injection nozzle formed at one end of the body, and a radial outside provided in the opening at the other end of the body. In a medical syringe barrel that includes a protruding flange
The body portion has an intermediate body portion having an outer diameter smaller than the outer diameter of the injection nozzle portion, and an outer diameter having the same outer diameter as the outer diameter of the injection nozzle portion formed between the flange portion and the intermediate body portion. A medical syringe barrel characterized by including a large outer diameter body.
The medical syringe barrel according to claim 1, wherein the axial length of the large outer diameter body portion is set to 1/3 or less of the axial length of the body portion.
A medical treatment in which at least one syringe barrel is held in a nest having a flat plate member provided with at least one opening and a tubular member having one end coupled to the opening and formed as a protruding end with the other end protruding upward. In the packaging of the syringe barrel for
The syringe barrel held in the nest includes a cylindrical body for accommodating the internal liquid, a cylindrical injection nozzle formed at one end of the body, and the other end of the body. It has a flange that protrudes outward in the radial direction provided in the opening.
The body portion has an intermediate body portion having an outer diameter smaller than the outer diameter of the injection nozzle portion, and an outer diameter having the same outer diameter as the outer diameter of the injection nozzle portion formed between the flange portion and the intermediate body portion. Including large outer diameter body
The inner diameter of the tubular member is set to be larger than the outer diameter of the large outer diameter body portion and smaller than the outer diameter of the flange portion.
A package of a medical syringe barrel, wherein the flange portion abuts on a protruding end of the tubular member, and at least a part of the body portion is held in the tubular member.
The package of a medical syringe barrel according to claim 3, wherein the axial length of the large outer diameter body portion is set to 1/3 or less of the axial length of the body portion.